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Recruiting NCT07103044

NCT07103044 Early Achievements - Shaping Early Language and Literacy Skills

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Clinical Trial Summary
NCT ID NCT07103044
Status Recruiting
Phase
Sponsor Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Condition Developmental Language Disorder
Study Type INTERVENTIONAL
Enrollment 360 participants
Start Date 2021-08-26
Primary Completion 2026-09-30

Eligibility & Interventions

Sex All sexes
Min Age 45 Months
Max Age 65 Months
Study Type INTERVENTIONAL
Interventions
Early Achievements - Shaping Early Language and Literacy Skills

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 360 participants in total. It began in 2021-08-26 with a primary completion date of 2026-09-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Language skills are important for long-term reading comprehension success. Yet there are limited instructional approaches available for prekindergarten (pre-K) teachers to use in their inclusive classrooms to boost literacy-related language skills in children with and without language delays or disorders. In the first part of this study, the investigators will develop a teacher training program focused on building pre-K children's language-based literacy skills. Teachers will be trained and will use the strategies that they learn during literacy-related activities in their inclusive pre-K classrooms. Their students' language-related literacy skills will be measured before and after their training. Based on teacher feedback and child assessment information, the training program will be revised. In the final part of the study, a preliminary randomized control trial (RCT) will be done using the revised training approach. The results of the RCT will help the investigators know if the teacher training program helps to improve the effectiveness of teachers' instruction and their students' development of language-related literacy skills. The primary goal of this research study is to determine whether study-trained pre-K teachers in inclusive early childhood education classrooms use more effective teaching strategies than teachers who do not receive the training. A secondary goal of this research study is to determine if this teacher training program strengthens language-related literacy skills for students with and without language disorders or delays. The research team hypothesizes that teachers who participate in the training program will use effective teaching strategies more often than teachers who do not receive the training. Additionally, the investigators predict that teachers who receive the training will feel more confident teaching early language-based literacy skills to their students (with and without language delays/disorders) than teachers who do not receive the training. Researchers also predict that students taught by teachers who receive the training will perform better on language tests when compared to their peers in classrooms where the teacher training program was not used.

Eligibility Criteria

Inclusion Criteria for Teachers * Having students in the identified age range * Having at least one child in their classroom who receives language-focused related services, has an existing diagnosis of language delay or disorder, or meets study criteria for DLD on the research measures * Planning to teach for the duration of the training period. Inclusion Criteria for Students in the DLD group: * use phrases containing a noun and a verb in most spontaneous utterances (per teacher report) * are exposed to English \>50% of their time at home (per parent report). receive language-focused related services, have a prior diagnosis of language delay or disorder, or meet study criteria for language delay on the CELF P-3 and/or CUBED NLM. * CELF P-3: score more than 1 standard deviation below the mean on at least one subtest * NLM criteria: receives two Listening Retell score raw score of \<5 on Fall measures or \<7 on Winter measures * between approximately 45-65 months of age Inclusionary criteria for students in the TD group: * cannot have an identified DLD or developmental disability and does not meet above criteria for language delay/disorder * between approximately 45-65 months of age. * are exposed to English \>50% of their time at home (per parent report) Exclusion Criteria: Exclusionary criteria for both the DLD group and TD group: * having a visual or hearing impairment after correction (per parent report) * having a motor impairment that renders them unable to reach and grasp objects or sit independently * score more than1.5 standard deviation below the mean on the Mullen Scales of Early Learning Visual Reception subscale * This criterion will be evaluated on a case-by-case basis at the PI's discretion as children's performance may be affected by any of a number of factors and a single response variation may result in a child missing the cut-off while clearly succeeding cognitively in the classroom.

Contact & Investigator

Central Contact

Rebecca Landa, PhD

✉ landa@kennedykrieger.org

📞 443-923-7591

Principal Investigator

Rebecca Landa, PhD

PRINCIPAL INVESTIGATOR

Hugo W. Moser Research Institute at Kennedy Krieger Institute

Frequently Asked Questions

Who can join the NCT07103044 clinical trial?

This trial is open to participants of all sexes, aged 45 Months or older, up to 65 Months, studying Developmental Language Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07103044 currently recruiting?

Yes, NCT07103044 is actively recruiting participants. Contact the research team at landa@kennedykrieger.org for enrollment information.

Where is the NCT07103044 trial being conducted?

This trial is being conducted at Baltimore, United States.

Who is sponsoring the NCT07103044 clinical trial?

NCT07103044 is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. The principal investigator is Rebecca Landa, PhD at Hugo W. Moser Research Institute at Kennedy Krieger Institute. The trial plans to enroll 360 participants.

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